Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures

Not Applicable

Not yet recruiting

• Conditions: Virtual Reality; Anxiety; Pain
• Interventions: Device: VR with positive psychology; Device: VR without positive psychology

• Registration Number: NCT05941390
• Lead Sponsor: Assuta Ashdod Hospital

Brief Summary

A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will.

After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology.

Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-12
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-03
• Study Start: 2023-09-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
• amniocintesis -single tone,gestional age 16-24 week,
• hysteroscopy-women age 18-60 , diagnostic procedure,

Exclusion Criteria

• ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
• amniocintesis- Known fetal malformations, amnionitis
• hysteroscopy-pregnancy, PID

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR with sound	VR with positive psychology	patients undergoing one of the procedures using VR device with sound
VR without sound	VR without positive psychology	patients undergoing one of the procedures using VR device without sound

Primary Outcome Measures

Name	Time	Method
stress cortisol saliva level	up to 5 minutes after the procedure	each arm after the procedure will be mesured stress cortisol level in saliva

Secondary Outcome Measures

Name	Time	Method
pain levels	up to 5 minutes after	each arm after the procedure will fill pain questioner. pain questioners using visual analog score. 0- to 10, while 0 is no pain at all, 10 is the worse pain ever felt.the patients will fill the questioner before and after the procedures.
anxiety levels	up to 5 minutes after	each arm after the procedure will fill anxiety questioner. anxiety questioner using the short depression , anxiety and stress scale (DASS-21). the patients will fill the questioners before and after the procedures.